Manufacturing Technician-Medical Device-Contract-Santa Clara, Ca

  • Materials and Inventory management for Pilot Line processes
  • Work Order and Non-conformance management for Pilot Line processes via ERP
  • Assemble various catheter designs and assist in developing design improvement, assembly approaches, and fixtures for articulating catheter devices.
  • Execute rework or deviation instructions with coordination with manufacturing engineering.
  • Identifies and escalates nonconforming products and supports root cause investigation alongside manufacturing engineering.
  • Perform testing, experimentation, and analysis.
  • Meet catheter Pilot Line yield and productivity goals.
  • Support processes and equipment qualification activities
  • Train manufacturing/Pilot Line operators and Technician processes and techniques
  • Assist manufacturing/Pilot line/process/R&D engineers in resolving product and process problems.
  • Complete documentation such as Lot History Records per GMP requirements
  • Support the introduction of new products onto the manufacturing line.
  • Follow GMP guidelines
  • Support experimentation to uncover key relationships between process variables and product performance.
  • Identifies and escalates nonconforming products and supports root cause investigation alongside manufacturing engineering
  • Provide day-to-day coordination and scheduling of floor activities with materials and planning Pilot Line teams.
  • Hands on Interview for New employees on Pilot Line.
  • Assist in the selection of new employees as required to meet business needs.
  • Provide timely feedback to employees on performance.
  • Communicate with staff on a regular and consistent basis as defined.
  • Keep management informed of issues & concerns in a timely manner.
  • Ensure staff are trained in all relevant procedures.
  • Ensure housekeeping standards are maintained within areas of charge.

Required Knowledge/Skills, Education, And Experience

  • ­­High school degree
  • 5+ years of experience with medical field or relevant companies is required.
  • Computer programs required; Ability to work with Excel, Word, Agile, SAP are preferred.
  • Have knowledge for end-to-end processes and have hands on skill set equivalent to operator III level.
  • Work on pilot line supporting new product development and able to build prototypes and provide feedback to engineers.
  • Support activities related to equipment qualification or process validation.
  • Able to execute protocols and document test results or draft work instructions.
  • Red line or create procedures electronically.
  • Able to perform simple failure analysis independently or assist engineers for more complicated failure analysis and able to provide feedback or ideas for continuous improvement.
  • Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.

Pay Rate-DOE

Please send resume to kjohnson@nelsoninteractive.net

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